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Bowel Management Program for Low Anterior Resection Syndrome

This study is comparing two ways to treat Low Anterior Resection Syndrome (LARS) in people who have had rectal cancer surgery. LARS is a common condition after surgery where part of the rectum is removed, causing changes in how your body passes stool. The study is testing if a bowel management program that includes a retrograde rectal enema (RRE) is better than medical management alone. The medical management includes dietary fiber, loperamide hydrochloride (an anti-diarrhea medicine), and pelvic floor physical therapy. You could be eligible if you are at least 18 years old, have moderate to severe LARS, and your symptoms haven't improved with standard medical care for 3-6 months. The study will look at how well these treatments reduce fecal incontinence over up to one year. The current status of this study is unclear.

Study design
This interventional study plans to enroll 80 participants and will compare two groups: one receiving a bowel management program with RRE and medical management, and another receiving only medical management.
What's involved
If you join, you would be in one of two groups for one year, receiving dietary fiber, loperamide hydrochloride, and pelvic floor physical therapy. One group would also self-administer an individualized enema regimen via the rectum.
Compensation
Not stated in the trial record.
Follow-up
All participants will be followed up at 1 month, 3 months, and 1 year after the study intervention ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06424522

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

Recruiting
NAAges 18+InterventionalSupportive care
Ohio State University Comprehensive Cancer Center
~80 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Dietary FiberEnema AdministrationLoperamide HydrochloridePhysical TherapyQuestionnaire AdministrationX-Ray Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fecal incontinence
Measured over Up to 1 year from start of treatment
+1 more outcome measured

Conditions

Low Anterior Resection Syndrome
Rectal Carcinoma

Explore related trials

Low Anterior Resection SyndromeRectal Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Alessandra C Gasior, DO · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years old
Moderate to Severe LARS diagnosis
Patients with history of rectal cancer that was treated with proctectomy
Has undergone standard medical management without improvement of symptoms for 3-6 months

Exclusion

Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit
Patients with any chemo or radiation therapy in the last 6 months
Patients who currently have colorectal cancer
Patients with recurrent colorectal cancer
Patients who have undergone a colorectal surgical procedure within the last three months
Patients with progressive neurological disease
Patients with active or recurrent sacral infection
Patients \< 18 years old
Active sacral nerve simulator
Pregnant or planning to become pregnant during the treatment portion of the study
Altered mental status or mental disability that would alter ability to self-administer enema
Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)

What this trial measures

  • Fecal incontinenceUp to 1 year from start of treatment

    Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.

  • Effectiveness assessed using LARS validated scoring toolUp to 1 year from start of treatment

    Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.